Label: REGEMARINE EXTREME- octinoxate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 42248-112-01 - Packager: Zenith Medicosm SL
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 21, 2012
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INGREDIENTS AND APPEARANCE
REGEMARINE EXTREME
octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42248-112 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 15 mL in 200 mL Inactive Ingredients Ingredient Name Strength MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) PROPYLPARABEN (UNII: Z8IX2SC1OH) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) DIMETHICONE (UNII: 92RU3N3Y1O) XANTHAN GUM (UNII: TTV12P4NEE) ROSA MOSCHATA OIL (UNII: J99W255AWF) WATER (UNII: 059QF0KO0R) MINERAL OIL (UNII: T5L8T28FGP) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) PEG-8 STEARATE (UNII: 2P9L47VI5E) TROLAMINE (UNII: 9O3K93S3TK) SOYBEAN (UNII: L7HT8F1ZOD) CHONDRUS CRISPUS (UNII: OQS23HUA1X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) CARBOMER 934 (UNII: Z135WT9208) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLPARABEN (UNII: A2I8C7HI9T) COLLAGEN, SOLUBLE, FISH SKIN (UNII: 8JC99XGU4W) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) PEG-6 STEARATE (UNII: 8LQC57C6B0) PEG-32 STEARATE (UNII: 33GX5WQC0M) STEARIC ACID (UNII: 4ELV7Z65AP) PANAX GINSENG FRUIT (UNII: E35T4MOI3E) PEG/PPG-20/23 DIMETHICONE (UNII: XK68QT7HWY) FUCUS VESICULOSUS (UNII: 535G2ABX9M) PELVETIA CANALICULATA (UNII: 8U1M44KESN) ALLANTOIN (UNII: 344S277G0Z) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42248-112-01 200 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/15/2011 Labeler - Zenith Medicosm SL (464239694) Registrant - Zenith Medicosm SL (464239694) Establishment Name Address ID/FEI Business Operations Zenith Medicosm SL 464239694 manufacture